Chemicals Regulation Division

Labelling Handbook
Volume 4- Requirements for Labels of Products used under Permits for Trial Purposes

The Labelling Handbook

Volume 4

Requirements for Labels of Products used

under Permits for Trial Purposes

Contents
1. INTRODUCTION 136

2. LABELLING CATEGORIES 136

3. LABELLING REQUIREMENTS 137

3.1 General Labelling Requirements 137

3.2 Specific Labelling Requirements 137

APPENDICES 139

Appendix 1: Personal Protective Equipment 139

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Volume 4- Requirements for Labels of Products used under Permits for Trial Purposes

1. INTRODUCTION
Permits for Trial Purposes are defined as covering ‘any substance, preparation or
organism made available for research and development work involving the release into
the environment of an authorised or unauthorised active substance and/or product that is
not authorised for the proposed use’. The ‘pesticide’ must be stored, handled, applied
and disposed of in accordance with the Code of Practice for the Safe Use of Pesticides
on Farms and Holdings and should preferably be declared on the container label, or as a
second choice, on a separate leaflet accompanying the container.

Details of making applications for Permits can be found on the HSE website Applicant
Guide. This guidance applies to labelling any permit whether issued by the
Administrative process or subject to a technical assessment.

2. LABELLING CATEGORIES
There are two labelling categories which apply to the four different types of Permit for
Trial Purposes and the two categories have their own labelling requirements:

Category A:
Products which have a commercial authorisation for uses other than those for which the
Permit for Trial Purposes was obtained and for which an agreed label exists.

Category B:
Formulations which have not received a commercial authorisation and for which no
agreed label exists (these would include for example formulations of new substances,
major formulation changes of existing products).

Important Note

For all experimental samples, and always those under Category B it is advisable to
obtain a written receipt for the sample and the safety information. This may take the
following form:

I………………………..acknowledge receipt of sample ………………(code), and of

the relevant safety information.
Signed:
Address/organisation:

Date:

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3. LABELLING REQUIREMENTS

3.1 General Labelling Requirements

3.1.1 You do not need to submit a draft label with the application but will need to
produce a label for the experimental product once the permit has been issued in
the line with the following:

(a) Guidance in this Volume 4

(b) The general guidance in Volumes 1 to 3

(c) All of the information on the actual Permit issued by HSE must be conveyed
to the user for the safe handling and use of the product/formulation (for
example conditions of use, operator protection, environmental protection,
other specific restrictions and conditions of storage as appropriate).

3.1.2 The labelling requirements differ slightly between labelling categories A and B :

Category A:
The existing authorised label may be used if appropriate in which case the
Important Information/Safety Precautions/ Directions For Use should be suitably
amended in line with the requirements of the Permit and a statement to identify
the use as experimental should be included (for example as a separate ‘stick-on’
label).

Category B:
The available chemical and biological information must be taken into account in
the preparation of the label, leaflet and data sheet and this includes ALL of the
information on the Permit relating to the safe handling and use of the
product/formulation.

3.2 Specific Labelling Requirements

In addition to the information on the Permit relating to the safe handling and use of the
product/formulation and the guidance in Volumes 1 to 3 in this Handbook the following
additional information must be conveyed to the user (some of these requirements will
already be met if you are carrying out experimental work with a product with an
authorised label):

i) The words ‘EXPERIMENTAL USE’ for category A formulations and

‘EXPERIMENTAL SAMPLE/FORMULATION’ for category B formulations.

ii) The phrase “Product intended for experimental use, not fully characterised, handle
with extreme care”.

iii) Identification of the formulation sample either by the product code or tradename
(there must also be some means of identifying the batch on the label or container).

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iv) The name and content of each active substance, as specified on the Permit, must
be given (usually included in a single ‘contents statement’ with the formulation type).
If one has not been agreed, the chemical name according to IUPAC rules (as
interpreted by the Royal Society of Chemistry) or if not available, the Company code
for the active substance should be used.

v) A statement of the products classification together with the appropriate hazard

symbol(s) and risk and safety phrase(s), where this is known.

However, where the toxicological data are insufficient to permit full classification the
sample should be labelled ‘CAUTION SUBSTANCE NOT YET FULLY TESTED’

vi) For any Permit where we have not carried out an operator exposure assessment the
following personal protective equipment (PPE) is required to be specified on the
Permit:

‘Personal protective equipment must be worn when handling and applying the
product in accordance with the guidelines given in the 'Code of Practice for Using
Plant Protection Products Annex E - Guidance on using personal protective
equipment'.

This will apply to the following

a) For all Administrative Permits for Trial Purposes. However if you are
using a Category A formulation and the experimental use falls within the
uses already authorised then the same PPE may apply. However, if there
are any differences then PPE in line with the Code of Practice must apply
(for example in the case of higher doses, different application technique).

b) For all Assessed Permits if we have not carried out a full toxicological and
operator exposure assessment.

For additional guidance, a summary of the specific PPE for various formulations and
operations based on the Code of Practice is detailed in Appendix 1.

vii) Appropriate medical advice if applicable must appear.

viii) A warning that the container or pack must not be re-used for any purpose, unless
there is a specific instruction about re-use, re-charging or re-filling and the pack is
designed for this (this is only required for products which are classified as very toxic,
toxic or harmful or where the classification is unknown).

ix) For emergencies the name, address and telephone number (extension number or
department if appropriate) of the Company must appear.

x) Any additional information required under Section 6 of the Health and Safety at
Work Act 1974.

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Appendix 1 - Personal Protective Equipment

1. All products

1.1 A Permit for Trial Purposes (including all Administrative Permits) may specify that
PPE be worn in accordance with the guidelines given in the 'Code of Practice for
Using Plant Protection Products Annex E - Guidance on using personal
protective equipment'. The following is a summary of the required PPE that must
be worn for different formulation/operations as set out in the Code of Practice and
which must appear on the experimental product label

• All situations for all products • Coverall,

• Gloves,
• Boots

In addition to the above, the following PPE are required for specific operations and
formulations as specified

• Preparing liquid products • Apron

• Handling contaminated equipment and containers after • Face-shield
use of products applied as a liquid • Hood
• Handling and applying dusts • Face-shield
• Handling contaminated equipment and empty • Hood,
containers after applying dusts • Respiratory Protective Equipment
• Handling and applying ‘very toxic’ granules (or where (RPE) (full-face type if product is ‘very
classification unknown) toxic’ or ‘classification unknown’),
• Applying fogs, smokes or gases

• Applying to targets above waist height • Face-shield

• Applying indoors (for example, to protected crops) • Hood
• Cleaning equipment used to apply pesticides (if not
liquid or dust- see above)
• Reduced-volume spraying outdoors by vehicle-mounted • Face-shield
downward-directed sprayers (without a closed cab) or • Hood for ‘harmful’ or ‘irritant’ products
hand-held sprayers or ‘classification unknown ‘

• Reduced-volume spraying by indoor sprayers and • Face-shield,

outdoor air-assisted broadcast sprayers (without a • RPE
closed cab) • Hood,
• Apron for ‘harmful’ or ‘irritant’ products
or ‘classification unknown’

• Applications using ATV-mounted or trailed equipment • Face-shield

• Applying from tractors without closed cabs • Hood

See Notes below for clarification of PPE type and also Section 2 for additional PPE
for products containing micro-organisms

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Notes

(a) Coveralls
Choose coveralls for the particular purpose, in line with the following table.

Purpose CEN type Description

Protection against: Type 3 Chemical protective clothing where liquid cannot
liquid jets pass through the connections between different parts
of the clothing
Sprays Type 4 Chemical protective clothing where spray cannot
pass through the connections between different parts
of the clothing
Solid particles Type 5 Reusable and limited-use protective clothing which
particles cannot pass through
Liquid splashes and solid Type 6 Reusable and limited-use protective clothing offering
particles limited protection against liquid splashes and
aerosols and solid particles

(b) Gloves
Unless the pesticide label or a specific COSHH assessment says otherwise, gloves should be
made from nitrile rubber, be at least 0.5 millimetres thick and at least 300 millimetres long. Gloves
should be taken off when entering ‘clean’ areas such as tractor cabs.

(c) Boots
Appropriate boots are wellington boots or waterproof footwear.

(d) Face-shields
Choose faceshields that give full protection of your face and do not mist up when you use them
(anti-mist visors).

(e) Respiratory Protective Equipment (RPE)

Your choice will depend on the product label and a COSHH assessment. Consider the following as
the basic conditions.

• Potential dust particles or Use an EN 149 particle-filtering half mask FF2-SL or spray droplets in
the air EN 140 + 143 half mask connected to particle filter P2

• Potential vapour in the air Use an EN 140 + 141 half mask connected to combined filters A1P2

(f) Open-backed cabs

Open-back cabs (including cabs with open rear windows) do not count as closed cabs as spray
can be drawn inside.

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2. Products containing a micro-organism

For an experimental product containing a microorganism, the PPE specified in

Section 1. above are appropriate plus the minimum PPE as set out below:

i) For solid formulations-

Wear suitable protective clothing (coveralls), suitable protective gloves and
suitable respiratory protective equipment* when handling the product or
applying the product. *Disposable filtering facepiece respirator to at least
EN149 FFP3 or equivalent.

ii) For Liquid formulations-

Wear suitable protective clothing (coveralls), suitable protective gloves and
suitable respiratory protective equipment* when handling the concentrate or
applying the product. *Disposable filtering facepiece respirator to at least
EN149 FFP3 or equivalent.

This PPE is required because all such products must carry the phrase ‘Micro-
organisms may have the potential to provoke sensitising reactions’:

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